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ACTIVE NOT RECRUITING Phase 3

Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma

NCT03710876 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, 1 of which must have been an anti-folate and platinum combination regimen. Eligible patients will be randomized 1:1 to either: 1. Treatment group: rAd-IFN + Celecoxib followed by Gemcitabine 2. Control group: Celecoxib followed by Gemcitabine Patients randomized to the treatment group will receive rAd-IFN administered into the pleural space via an Intrapleural catheter (IPC) or similar intrapleural device on study Day 1. The primary objective of this study is to compare the overall survival (OS) associated with rAd IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM

Interventions

  • DRUG Gemcitabine
  • BIOLOGICAL rAd-IFN
  • DRUG Celecoxib Oral Product

Study Locations (20)

Other

  • Institut Bergonie — Bordeaux
  • CHRU de Brest - Hopital Augustin Morvan — Brest
  • CHU de Caen - Hopital Cote de Nacre — Caen
  • CHRU de Lille — Lille
  • Institut Curie - Oncologie Medicale — Paris
  • Centre Hospitalier Lyon Sud — Pierre-Bénite
  • CHU de Nantes - Hôpital Nord Laennec — Saint-Herblain
  • Evangelisches Krankenhaus Hamm — Hamm
  • Universitatsklinikum Regensburg — Regensburg

California

  • University of California, Los Angeles (UCLA) - Medical Center — Los Angeles
  • University of California, San Francisco (UCSF) — San Francisco

Maryland

  • Marlene & Stewart Greenbaum Comprehensive Cancer Center — Baltimore
  • University of Maryland Medical Center — Baltimore

Florida

  • H. Lee Moffitt Cancer Center & Research Institute — Tampa

Minnesota

  • Masonic Cancer Center - University of Minnesota — Minneapolis

Pennsylvania

  • University of Pennsylvania Abramson Cancer Center — Philadelphia

New South Wales

  • Chris O'Brien Lifehouse — Camperdown

Victoria

  • Monash Medical Centre — Clayton

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2019-01-21
Est. Completion 2026-04
Phase Phase 3

Sponsor

Ferring Ventures Limited

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03710876

The ClinicalTrials.gov registry entry for NCT03710876 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ferring Ventures Limited, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Malignant Pleural Mesothelioma appearing as the primary indexed condition, and to 3 interventions — of which Gemcitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03710876 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03710876 about?

NCT03710876 is a clinical study titled "Efficacy & Safety of rAd-IFN Administered With Celecoxib & Gemcitabine in Patients With Malignant Pleural Mesothelioma". This study will evaluate intrapleural administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in combination with Celecoxib and Gemcitabine in patients with histologically confirmed Malignant Pleural Mesothelioma (MPM) who have failed a minimum of 1 treatment regimen and a maximum of 2 ...

What is the current status of trial NCT03710876?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 53 participants. The study started on 2019-01-21. Estimated completion is 2026-04.

What conditions does trial NCT03710876 study?

This clinical trial studies the following conditions: Malignant Pleural Mesothelioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03710876?

The interventions under investigation include: Gemcitabine (DRUG), rAd-IFN (BIOLOGICAL), Celecoxib Oral Product (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03710876?

This trial is sponsored by Ferring Ventures Limited, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03710876 being conducted?

This trial has 20 study locations across California, Florida, Maryland, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial